MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for AMPLATZER CRIBRIFORM OCCLUDER 9-ASD-MF-035 manufactured by Aga Medical Corporation.
[184305238]
Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[184305239]
On (b)(6) 2020, a 35mm amplatzer cribriform occluder was selected for implant in a patient with a multifenestrated asd. The physician proceeded to complete the procedure according to the ifu, but after the device was deployed a small shunt across the septum was noted through tee. The physician decided to retract the device and remove the device from the patient. Once the 35 mm amplatzer cribriform occluder was removed it was found to have what appeared to be a clot on the device. The physician ordered additional heparin and rechecked the act. The act was confirmed at 270. A new 35 mm amplatzer cribriform occluder was selected for implant and through tee it was confirmed to have successfully occluded the multifenestrated asd. The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00124 |
| MDR Report Key | 9856279 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | AGA MEDICAL CORPORATION |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER CRIBRIFORM OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-19 |
| Model Number | 9-ASD-MF-035 |
| Catalog Number | 9-ASD-MF-035 |
| Lot Number | 7235019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGA MEDICAL CORPORATION |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |